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POSE funding

USGI raises over US$19 million to aid POSE commercialisation

Money will also fund the crossover study as part of the ESSENTIAL trial, health economics research and several important studies in Europe

USGI Medical has raised over US$19.5 million in the latest round of financing, bringing the total raised in the last year to $36 million in equity and debt. This funding will provide USGI with the capital resources to extend the commercial launch of POSE (Primary Obesity Surgery, Endolumenal) in Europe and the Middle East and begin pre-commercialisation activities for the procedure in the US, as the company completes the follow-up phase of its US pivotal study known as ESSENTIAL, and prepares to submit an application to FDA for approval. This money will also fund the crossover study as part of the ESSENTIAL trial, health economics research and several important studies in Europe.

"This infusion of capital represents a very important milestone for USGI," said Scott Moonly, President and CEO, USGI Medical. "This positions us to expand further in Europe and the Middle East and launch our technology into new markets. In the US, we are actively working with the ESSENTIAL trial investigational sites to offer the POSE procedure to crossover patients who initially underwent a sham procedure as part of the protocol. We are collecting follow-up data from the study and preparing the documentation and information that will be needed for submission in a regulatory package to the FDA. We would like to thank our investors for their long-term support as we work to offer overweight patients struggling with diet and exercise and who don't want surgery, a non-invasive treatment option."

While the device remains investigational for weight loss in the US, POSE is now a widely used weight loss procedure outside of the US, where physicians have performed over 3,500 procedures. In clinical studies, patients lost up to 62% of their excess weight after a year, which equates to between 40 to 45lbs lost, on average.

The Incisionless Operating Platform, including the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors has both CE Mark and US 510(k) Clearance. As a treatment for obesity, however, the safety and effectiveness of the device has not been established in the US. The device is considered an investigational device in the US and is thereby limited by Federal Law to investigational use for this application.

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